Human embryonic stem cell-related inventions, legal situation

Legal situation in Germany

On November 27, 2012, the German Federal Court of Justice (Case X ZR 58/07 – Stem cells) finally decided on the controversial Brüstle/Greenpeace case that led in 2011 to the CJEU stem cell decision (case C-34/10).

The CJEU ruled in decision C34/10 that human embryonic stem cell-related inventions are excluded frompatentability if, in order to carry out the invention, prior destruction of human embryos is or was required by the technical teaching of the patent. Even if the destruction is not mentioned in the patent, the exclusion from patentability can apply. For example, as in the case at issue, an invention relating to the use of a well-established embryonic stem cell line would be excluded from patentability if the original creation of the cell line had entailed destruction of human embryos.

Further, the CJEU ruled that the term “embryo” includes any human egg cell after fertilization, or any other cell which is capable of developing into a human being, such as a non-fertilized human egg cell into which a cell nucleus has been implanted or a human egg cell undergoing parthenogenesis. The German Federal Supreme Court had to apply this ruling of the CJEU to its Brüstle/Greenpeace case.

The German Federal Court of Justice has now reversed the judgment of the Federal Patent Court and maintained the patentin a restricted version of the patented claims containing the proviso that the embryonic stem cells are not obtained by destruction of human embryos. The Federal Supreme Court clarified that the patentis maintained insofar as the human stem cells are obtained by non-destructive methods.

Sufficency of disclosure criteria for stem cell related inventions

The German Federal Court of Justice held that the integration of the proviso in claim 1 of the patent was enough to avoid the exclusion from patentability. The Court appeared to consider that, for the purposes of assessing whether the claim fell into the exclusion or not, it was not relevant whether the claim was enabled by the disclosure of the specification. The Court stated that ‘it may be left open’ whether practical ways were available to the skilled person for obtaining stem cells from embryos without destroying them. If such ways were available, they would be encompassed by the claims even if they were not disclosed in the patent. On the other hand, if the skilled person could not carry out the method of the claim based on the disclosure of the specification, it would not matter because the claim could not in any case cover excluded methods as these were specifically excluded from the claim by the proviso (item 32 of the reasons).

Nonetheless, the requirements of sufficiency of disclosure must still be met by the patent as a whole. The Court therefore considered the issue of sufficiency separately from the issue of exclusion from patentability. In this particular case, the Court held that the requirement for sufficiency of disclosure was fulfilled, because the specification disclosed that ‘embryonic stem cells’ include ‘embryonic stem-like cells’ which can be obtained from embryonic germ cells and thus do not require desruction of a human embryo.

Use (destruction) of embryos with arrested development is not considered as embryo destruction

Further, pursuant to the judgment X ZR 58/07, in Germany patent claims directed to stem cells are allowed if the development of the human embryos which served as origin for the stem cells was arrested. The use of such arrested human embryos is not considered as a destruction of a human embryo (see item 32 in the reasons of the decision).Legal situation according to the European Patent Convention

According to the EPO Guidelines for Examination, EPO examiners are required to establish that a claimed product is not ‘exclusively obtained by a method which necessarily involved the destruction of human embryos’ by reference to the teaching of the application, including the relevant disclosure in the description.

On 11th April 2013 the patent EP1040185B1- which claims priority from the patent which was decided on in Case X ZR 58/07 in Germany- was revoked in opposition proceedings.

In the course of the opposition proceedings the claims of EP1040185B1 had been amended in the same way as the claims during the German proceedings, namely to include the proviso in claim 1 that the embryonic stem cells are not obtained by destruction of human embryos. In consequence, EP1040185B1 was revoked on the grounds of “added matter” pursuant to Art. 123(2) EPC. The proviso (limiting the claimed subject matter to methods using embryonic stem cells that were not obtained by destruction of human embryos) was not considered to be admissible by the Opposition Division under the criteria laid out by the Enlarged Board of Appeal in decision G2/06, as the claimed subject matter was reduced to methods which a skilled person was not able to carry out at the filing date. The inadmissible proviso was held to represent added subject matter, and the patent was revoked.

It would appear, however, that the EPO Opposition Division reached their decision at least in part due to a different interpretation of the facts from the German Federal Court of Justice. The Opposition Division considered that the claim containing the proviso could not be carried out by the skilled person at the filing date, whereas the German Federal Court of Justice held that the claim could be carried out by the skilled person due to the possibility of using embryonic stem-like cells.

The EPO Decision is open to appeal.

Legal situation in the UK

In the UK, no jurisprudence is yet available which clarifies how the CJEU decision will be interpreted in the UK. However, the UK IP Office has issued a guidance note explaining their practice in the light of the decision. Following decision C34/10, the UK IPO confirm where the implementation of an invention requires the use of cells that originate from a process which requires the destruction of a human embryo, the invention is not patentable in the UK. For example, an invention will not be patentable if its implementation requires the use of a human embryonic stem cell line the establishment of which originally required the destruction of a human embryo. However, no guidance is yet available either from the UK IPO or the UK courts as to the evidence which will be needed to demonstrate that destruction of a human embryo is not required. The guidance note also confirms that the UK IPO will follow the CJEU judgment in not excluding from patentability inventions that are for therapeutic or diagnostic purposes that are applied to, and useful to, the human embryo, and that the UK IPO will adhere to the CJEU’s broad definition of ‘human embryo’.